FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

FDA Targets Florida Devicemaker for Repeated Violations

Nov. 16, 2017
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The FDA cited devicemarker Applied Neuroscience of Largo, Florida for failing to correct numerous nonconformities dating as far back as 2014.

Over the course of two days in mid-July, the FDA conducted an inspection at the facility and observed in a Form 483 that seven of eight issues identified were repeat deficiencies, including a lack of procedures for design control, as well as inadequate procedures for quality audits, adverse event reporting, and controlling purchased products and documents.

For example, no training was provided to the executive assistant who had been conducting quality audits at the facility, the investigator said.

Another repeat deficiency identified during the July inspection was the firm’s procedure for management reviews, which was deemed inadequate because it did not include requirements for the review of the suitability and effectiveness of the quality system and for the results of the quality system reviews to be documented.

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